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Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children

Sponsor
Universidad Tecnologica de Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT04717778
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
4
Actual Duration (Days)
159.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk)

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk
 N/A

Detailed Description

  • The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.

  • The group was given a brushing technique using a model and 2 videos were shown to reinforce the brushing technique and explanation of what was going to be done in the study.

  • Supervised tooth brushing was performed in a group of 5 people.

  • They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).

  • Each child was given 7 plastic cups each day and asked to pour their saliva into the cup when instructed.

  • The samples were taken with pH indicator strips and the result was recorded in personalized tables.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study was carried out in 21 first grade primary school children, they were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).The study was carried out in 21 first grade primary school children, they were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children
Actual Study Start Date :
Jan 13, 2020
Actual Primary Completion Date :
Jan 17, 2020
Actual Study Completion Date :
Jan 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: pH milk

Group of children who were given the different types of milk and only the pH was measured

Dietary Supplement: Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk
They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
Other Names:
  • cow´s milk, coconut milk, almond milk, soy milk and rice milk

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sociodemographic results [1 hour the sociodemographic data of all the children were taken.]

      The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.

    2. pH results [The average time of pH evaluation for each milk per child was an hour and a half.]

      30 minutes after tooth brushing, each child was asked for the first saliva sample (basal pH measurement). After taking the basal pH, each child was given a glass with 50 ml of the milk to be measured. Saliva samples were measured with pH indicator strips and the result was recorded on custom charts. The pH was taken at 5, 10, 20, 30, 40 and 50 minutes. The normality distribution test (Shapiro-Wilk) was applied to the quantitative variables, with p = 0.0001, so that the data present a non-parametric or free distribution. To assess whether there were differences between the pH of the groups, the Kuskal-Wallis test was applied. For basal pH, p = 0.0001, therefore the null hypothesis is rejected and we conclude that the basal pH level is different in the five milks. Average basal pH: Rice milk 7 Cow milk 6.9 Almond milk 6.6 Soy milk 6.4 Coconut milk 6

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Boys and girls from 3 to 6 years

    Exclusion Criteria

    • Boys and girls with allergies

    • Children with lactose intolerance

    Elimination criteria:
    • Boys and girls who do not want to participate at the time of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UNITEC Mexico City Mexico 11320

    Sponsors and Collaborators

    • Universidad Tecnologica de Mexico

    Investigators

    • Principal Investigator: Annia Avalos, Master, Universidad Tecnológica Centroamericana

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Annia Marisol Avalos Mejía, Principal Investigator, Universidad Tecnologica de Mexico
    ClinicalTrials.gov Identifier:
    NCT04717778
    Other Study ID Numbers:
    • 2019-100
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 22, 2021